As of 24 July 2018, the marketing authorisation for 14 veterinary medicines has been suspended for use in food-producing animals. This concerns specific anti-inflammatory and antimicrobial injection preparations for horses, cattle and pigs that contain the adjuvant diethanolamine.
Diethanolamine was on a European list of substances for which no maximum residue limit (MRL) was required.
This has changed recently when it became known that the substance is toxic to mice.
The CVMP (Committee for Veterinary Medicinal Products, an expert committee of the European Medicines Agency, EMA) carried out further research, in which it was established that without the establishment of an MRL, diethanolamine should no longer be used as an excipient in veterinary medicines for food-producing animals.
This finding led to the Netherlands proceeding with the suspension. Other European countries have also announced the suspension of these funds or will do so within short.
The Veterinary Medicinal Products Committee has established that sufficient alternative veterinary medicines are available in the Netherlands.
For this reason it has been decided that the products concerned can be recalled at wholesale level. There is no need to retrieve the products from the veterinarians or animal keepers. Other European countries, such as Belgium, see no reason to recall the products that have already been put on the market.
In horses it may be a consideration to exclude the animals for human consumption. In that case there are no public health risks when using veterinary medicines with the adjuvant diethanolamine.